Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
This is a proof-of-concept trial to compare 18F-FDG-PET/CT with NETSPOT (68Ga-DOTA-TATE), a commercially available radiotracer packet that utilizes 68Ga to image SSTR-specific tissue.
Detailed description
Patients meeting inclusion criteria will be consented at the time of scheduling. All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging with the AAA-provided dose. These scans will be performed no less than 8 hours, no more than 7 days apart. For patients undergoing same-day imaging, NETSPOT imaging will be performed prior to 18F-FDG-PET/CT. Following imaging, both 18F-FDG-PET/CT and NETSPOT imaging will be compared by trained neuroradiologists for SUV values and concordance with known sites of disease. Biopsies will be performed as is standard to verify all sites of primary or metastatic disease. Patients with oropharyngeal tumors will have HPV testing performed via the standard of care surrogate marker p16. Patients with p16-positive tumors will be recorded and analyzed separately for the above measures. Patients will be followed for a total of 1 year after the study and outcomes of overall survival, disease-free survival, presence and site of recurrence and development of metastatic disease will be recorded. All gathered data will be compared between reported 18F-FDG-PET/CT and NETSPOT imaging for true positive, true negative, positive predictive value and negative predictive value of patient groups.
Interventions
DRUGThe isotope 68Ga, NETSPOT and 18F-FDG-PET/CT
All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging
Sponsors
West Virginia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Proof of Concept
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with suspected or diagnosed HNSCC undergoing planned 18F FDG PET/CT at the time of primary diagnosis or after completion of treatment.
Exclusion criteria
Inability to undergo 18F-FDG-PET/CT imaging due to medical comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging | From Baseline up to day 7 post imaging | NETSPOT imaging will be at least equivalent to 18F FDG PET/CT in the detection and staging of HNSCC. This will be done using Standard Uptake Value (SUV) measurements. SUV max of \> 2.5 for 18F-FDG-PET and \> 1.5 for 68GA DOTATATE-PET/CT were used as thresholds of concern. Using the PET scan, investigators calculated the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging | From Baseline up to day 7 post imaging | The Combination of NETSPOT imaging and 19F FDG PET/CT will have increased specificity for detecting the primary site for HNSCC of unknown primary than 18F FDG PET/CT alone. This will be done using Standard Uptake Value (SUV) measurements. SUV max of \> 2.5 for 18F-FDG-PET and \> 1.5 for 68GA DOTATATE-PET/CT were used as thresholds of concern. Using the PET scan, radiologists can calculate the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proof of Concept The isotope 68Ga, available as NETSPOT and 18F-FDG-PET/CT per established protocol will both be administered
The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT: All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Proof of Concept | — |
|---|---|---|
| Age, Customized | 59.4 years STANDARD_DEVIATION 11.53 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging
NETSPOT imaging will be at least equivalent to 18F FDG PET/CT in the detection and staging of HNSCC. This will be done using Standard Uptake Value (SUV) measurements. SUV max of \> 2.5 for 18F-FDG-PET and \> 1.5 for 68GA DOTATATE-PET/CT were used as thresholds of concern. Using the PET scan, investigators calculated the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor.
Time frame: From Baseline up to day 7 post imaging
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Proof of Concept | Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging | OP-Primary Tumor | 7.21 (SUV) volume (cm3) | Standard Deviation 17 |
| Proof of Concept | Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging | OP-Nodes | 4.84 (SUV) volume (cm3) | Standard Deviation 17 |
| Proof of Concept | Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging | OC-Primary Tumor | 2.87 (SUV) volume (cm3) | Standard Deviation 17 |
| Proof of Concept | Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging | OC-Nodes | 2.46 (SUV) volume (cm3) | Standard Deviation 17 |
| Proof of Concept | Detection and Staging of Head and Neck Squamous Cell Carcinoma Using Standard Uptake Value for NETSPOT Imaging | Larynx-Nodes | 3.24 (SUV) volume (cm3) | Standard Deviation 17 |
Secondary
Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging
The Combination of NETSPOT imaging and 19F FDG PET/CT will have increased specificity for detecting the primary site for HNSCC of unknown primary than 18F FDG PET/CT alone. This will be done using Standard Uptake Value (SUV) measurements. SUV max of \> 2.5 for 18F-FDG-PET and \> 1.5 for 68GA DOTATATE-PET/CT were used as thresholds of concern. Using the PET scan, radiologists can calculate the standard uptake value (SUV), to compare the amount of an agent injected into the patient and the amount taken up by the tumor.
Time frame: From Baseline up to day 7 post imaging
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Proof of Concept | Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging | OC-Primary Tumor | 13.11 (SUV) volume (cm3) | Standard Deviation 18.25 |
| Proof of Concept | Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging | OC-Nodes | 5.96 (SUV) volume (cm3) | Standard Deviation 18.25 |
| Proof of Concept | Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging | Larynx-Nodes | 3.92 (SUV) volume (cm3) | Standard Deviation 18.25 |
| Proof of Concept | Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging | OP-Primary Tumor | 14.98 (SUV) volume (cm3) | Standard Deviation 18.25 |
| Proof of Concept | Detection of Primary Site for Head and Neck Squamous Cell Carcinoma Using SUV Measurements With NETSPOT Imaging | OP-Nodes | 7.59 (SUV) volume (cm3) | Standard Deviation 18.25 |